Kornimate/medical-research-clean huggingface dataset:
a two-part study to determine: best medication formulation and food effect

Conditions: Overactive Bladder

Summary: this is a two-part study. part 1 is designed to find the best modified release formulation of gw423753; part 2 is designed to use the selected formulation(s) from part 1 to find out if food affects the way the medication is processed by the body.


Eligibility criteria:
inclusion criteria: * healthy males \& females * part 1 ages 18-60 * part 2 ages 18-50 \& 65-80 * within normal weight range given your height * negative urine drug and alcohol test * willing to follow all study procedures exclusion criteria: * any clinically relevant abnormality identified on the screening physical examination, clinical laboratory tests, 12-lead ecg, or any other medical condition or circumstance making the subject unsuitable for participation in the study based on the investigator's assessment. * subjects with either a blood pressure measurement \> 150/90 mmhg, or a history of coronary disease and a blood pressure \> 140/90 mmhg, at screening. * history of drug or other allergy, which, in the opinion of the investigator, contraindicates their participation. * regular alcohol consumption averaging \>/7 drinks/week for women or \>/ 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of the first dose of study medication. * positive urine drug, alcohol or serum pregnancy test at screening and prior to dosing in each study session. * positive for hepatitis c antibody, hepatitis b surface antigen or hiv at screening. * treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to administration of study medication. * use of prescription or non-prescription drugs within 7 days or 5 half-lives (whichever is longer) prior to administration of study medication and during the study. by exception, use of acetaminophen at doses of ≤ 2 grams per day, the use of contraceptives (oral, depots, patches, etc.) and anti-hypertensive medications will be permitted. * use of vitamins or herbal/dietary supplements within 7 days prior to administration of study medication and during the study. * subject is unable and/or unwilling to adhere to lifestyle guidelines * subjects who have donated more than 500 ml of blood or plasma within 56 days prior to administration of study medication. * an unwillingness on the part of male volunteers to abstain from sexual intercourse with pregnant or lactating women; or an unwillingness to use a condom and another form of contraception (e.g., iud, birth control pills taken by female partner, diaphragm with spermicide) if engaging in sexual intercourse with a woman who could become pregnant from the time of the first dose of study medication until completion of follow-up procedures. * pregnant or lactating woman. a pregnancy test will be performed for all women at screening and prior to each dosing session to confirm eligibility. * the subject has a known hypersensitivity or idiosyncratic reaction to any drug chemical related to this study.

Keywords: gw427353 oral tablets, healthy adult subjects, food effect
primary prophylaxis of gastric varix bleed

Conditions: Cirrhosis

Summary: in patients who have never bled from gastric varix (gov2 and igv1), cyanoacrylate injection will be better than both beta-blocker therapy and no treatment in prevention of gastric variceal bleed. the investigators conducted a randomized controlled trial in patients with gastric varix (gov2 and igv1) who never bled before, to study the efficacy of treatment with cyanoacrylate injection versus beta-blocker versus no treatment in prevention of first bleed from gastric varices.

patients are followed up every 3 months or at the time of end point or complications.

Eligibility criteria:
inclusion criteria: * patients with gov2 with eradicated esophageal varix or igv1, who had never bled from gastric varix were included. exclusion criteria: * only esophageal varix, gov1 with gov2, acute bleed or past history of bleed from gastric varix, contraindications to beta-blocker therapy and cyanoacrylate injection. * prior injection of cyanoacrylate or sclerotherapy or variceal ligation or transjugular intrahepatic portosystemic shunt or balloon-occluded retrograde transvenous obliteration or balloon-occluded endoscopic injection sclerotherapy of gastric varix for prevention of bleeding from gv * patients already on beta-blocker or nitrates * undetermined origin of bleeding from esophageal varix or gastric varix * hepatic encephalopathy grade iii/iv * hepatorenal syndrome * hepatocellular carcinoma * presence of deep jaundice (serum bilirubin \> 10 mg/dl) * uremia * cerebrovascular accident * cardiorespiratory failure * pregnancy and patients not giving informed consent for endoscopic procedures
telehealth-enabled, real-time audit and feedback for clinician adherence (teach)

Conditions: Respiration, Artificial

Summary: the purpose of this trial is to evaluate if augmenting a usual audit and feedback implementation approach with telehealth-enabled support improves coordinated spontaneous awakening/breathing trials and patient outcomes for mechanically ventilated patients.

sedation and analgesia are utilized with invasive mechanical ventilation (imv) to improve patient comfort and synchrony with the mechanical ventilator. prolonged sedation, however, may result in increased time on imv and increased risk for ventilator associated pneumonia, delirium, and poor long-term cognitive outcomes. daily interruptions in sedation \[spontaneous awakening trials (sat)\] coordinated with daily spontaneous breathing trials (sbt) reduce mortality, increase ventilator free days, decrease intensive care unit (icu) length of stay, and reduces ventilator-associated events. coordination of spontaneous awakening and breathing trials (c-sat/sbt), however, are underutilized due to significant barriers to implementation and adherence. this cluster-randomized hybrid implementation/effectiveness trial will compare c-sat/sbt adherence and clinical outcomes in the presence of traditional audit and feedback implementation strategies alone or augmented with a novel telehealth-enabled, real-time audit and feedback for clinician adherence ("teach") implementation strategy.

Eligibility criteria:
inclusion criteria: * patient age \>=16 years admitted to study hospital icu * intubated and mechanically ventilated exclusion criteria: * patient with pre-existing brain death admitted to study hospital for organ donation * died within 24 hours of intubation

Keywords: invasive mechanical ventilation coordinated spontaneous awakening and breathing trials
anlotinib combined with pd-1 inhibitors for advanced/metastatic esophageal cancer

Conditions: Esophageal Cancer

Summary: efficacy and safety of anlotinib combined with pd-1 inhibitors as 2 or more lines treatment for heavily pretreated patients with advanced, metastatic squamous cell carcinoma of the esophagus.

the apec study is a multi-center, retrospective ,real-world study of anlotinib combined with pd-1 inhibitors for patients with histologically confirmed advanced and metastatic esophageal squamous cell carcinoma (escc) that progressed after 1or more lines of therapy, conducted at 8 sites in china. patients received anlotinib combined with pd-1 inhibitors , every 3 weeks for up to 2 years, until progression of disease, unacceptable toxic effects occurred, or withdrawal of consent. the primary end point was the progression-free survival (pfs)among all patients. secondary end points included adverse events (aes),objective response rate (orr) ,duration of response (dor), , and overall survival (os). tumor response was assessed per the response evaluation criteria in solid tumors (recist), version 1.1.

Eligibility criteria:
inclusion criteria: 1. male or female patients aged more than 18 years old; 2. ecog ps：0-2; 3. subjects with histologically or cytologically confirmed locally advanced and/or advanced esophageal squamous cell carcinoma(escc); 4. for local advanced or advanced escc, disease progression occurred after 1 or more lines systemic treatment previously; 5. have received anlotinib combined with pd-1 inhibitor treatment. exclusion criteria: 1. have used anlotinib before; 2. mixed with small cell cancer and/or other kinds of cancer ; 3. previously (within 5 years) or presently suffering from other malignancies; 4. symptomatic or uncontrolled brain metastases; 5. unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months or serious cardiac arrhythmia requiring medication; 6. pregnancy or lactation. -
comparative evaluation of the performance of different thromboplastin reagents on prothrombin time in situations of isolated extrinsic pathway factor deficiency or liver damage

Conditions: Hemorrhagic Disorders

Summary: primary purpose : compare the sensitivity of several thromboplastin reagents of various origins to prothrombin time and factor ii, v, vii and x assays in two different populations of patients : * patients with an isolated extrinsic pathway deficiency (acquired or congenital) of factor ii or v or vii or x. * patients with an hepatocellular insufficiency generally associated with coagulopathy (with an intensity proportional to the degree of hepatic impairment). results of this work should improve knowledge of sensitivity of the screening test represented by the prothrombin time, depending on the origin of thromboplastin reagent used, in relation with coagulopathies mentioned above, as well as the performance of factors ii, v, vii, x assays. this work would help to choice of the most suitable reagent for the needs of each hemostasis laboratory/center.


Eligibility criteria:
inclusion criteria: * plasma samples from patients addressed to the laboratory of the strasbourg university hospital (strasbourg france) collected and anonymized after completion of the routine testing. * patient with an isolated or combined extrinsic pathway factor deficiency (factor ii, v, vii, x). exclusion criteria: * patient treated with an oral anticoagulant treatment. * patient treated with a parenteral anticoagulant treatment (apart from therapeutic dosages of unfractionated heparin and low molecular weight heparin).
probiotic supplementation in children with adhd

Conditions: ADHD

Summary: this randomised, placebo controlled trial explores the effects of supplementation with a probiotic drink (kefir) in children diagnosed with adhd on behaviour, sleep, attention and the gut microbiome.

children with attention deficit hyperactivity disorder (adhd) can suffer debilitating symptoms, including problematic behaviour and sleep. dietary manipulations may be a helpful treatment option for children, but the most effective are highly restrictive, with little known about why they might work. optimising gut bacteria may help alleviate some of the symptoms of this condition via the gut-brain-axis. the consumption of a probiotic fermented drink (kefir) can positively influence composition of gut bacteria. the purpose of this study is to explore the effects of supplementation of a probiotic drink (kefir) on behaviour, sleep, attention and the gut microbiome in children diagnosed with adhd. in a six-week randomised controlled double-blind, placebo controlled trial, 70 children diagnosed with adhd (aged 8-13 years) will be randomised to be given either a probiotic drink (kefir) or a placebo drink. at the beginning and the end of the study a combination of questionnaires, cognitive assessment, sleep/physical activity measures and microbiome analysis will be employed to assess the effect of kefir consumption on symptoms of adhd and the gut microbiome.

Eligibility criteria:
inclusion criteria: * a previous diagnosis of adhd according to the dsm-iv or dsm-v criteria by a qualified health care professional. * children aged between 8 and 13 years at the time of study. * children with a comorbidity will be accepted. * both males and females exclusion criteria: * children currently undergoing a current course of behavioural therapy. * children with a reported milk allergy or lactose intolerance. * reported use of antibiotics, probiotics, antifungals or steroids in the past four weeks. * diagnosis of a gastrointestinal disorder e.g., inflammatory bowel disease or coeliac disease. * diagnosis of an auto-immune disease or compromised immunity.

Keywords: microbiome adhd probiotic kefir
safety and efficacy of teriflunomide (hmr1726) in multiple sclerosis with relapses

Conditions: Multiple Sclerosis

Summary: the primary objective of this study was to determine the safety and efficacy of teriflunomide in multiple sclerosis (ms) with relapses. secondary objectives were: * to determine the effect of teriflunomide on additional magnetic resonance imaging (mri) variables as well as clinical and quality of life measures. * to investigate the pharmacokinetic and pharmacodynamic relationships.

the total duration of the study period per participants was 46 weeks comprising 3 periods: * a 4-week screening period, * a 36-week double-blind treatment period, * a 6-week post-treatment follow-up period. participants who successfully completed the double-blind treatment phase were offered the possibility to continue study treatment in the extension study lts6048 - nct00228163.

Eligibility criteria:
inclusion criteria: * clinically confirmed multiple sclerosis \[ms\]; * expanded disability status scale \[edss\] score less or equal to 6; * two documented relapses in the previous 3 years, and one clinical relapse during the preceding year; * screening magnetic resonance imaging \[mri\] scan fulfilling the criteria for a diagnosis of ms. exclusion criteria: * clinically relevant cardiovascular, hepatic, hematologic, neurological, endocrine or other major systemic disease; * pregnant or nursing woman; * wish to parent children during the trial or following the trial (men and women were required to practice effective contraception during the trial and for 24 months after drug discontinuation); * prior treatment with interferon \[ifn\], gamma-globulin, glatiramer acetate, or other noncorticosteroid immunomodulatory therapies in the 4 months prior to the trial; * use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment; * any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
efficacy and safety of dwj1248 in patients with mild to moderate covid-19 compared to the placebo

Conditions: Mild to Moderate COVID-19

Summary: to evaluate the efficacy and safety after administration of dwj1248 in patients with mild to moderate covid-19 compared to the placebo.


Eligibility criteria:
inclusion criteria: * adults over the age of 19 as of the signed date in written consent * subjects with mild or moderate covid-19 according to rt-pcr test (total score of news is 0-6 or if one item is 3 points) * subjects who have symptoms within 7 days or 72 hours after diagnosis exclusion criteria: * subjects who cannot orally administer the investigational products * subjects who need administration of immunosuppressants * subjects who are allergic or sensitive to investigational products or its ingredients * subjects who have a history of drug and/or alcohol abuse within 52 weeks before screening * subjects who have been identified with uncontrolled concomitant diseases or conditions, including significant mental illness and social conditions, that may affect compliance with clinical trial procedures according to the determination of the investigators
clinical outcome after implantation of two different multifocal toric iols: liberty (677mty) and panoptix®

Conditions: Cataract

Summary: this study is to compare the rotational stability, visual outcome and patient satisfaction after implantation with either liberty 677mty, a multifocal diffractive-refractive iol based on eps technology manufactured by medicontur ltd. (zsámbék, hungary) or the multifocal toric iol panoptix®, manufactured by alcon.

according to numerous estimations, 15% to 29% of patients with cataract have more than 1.5 diopters of refractive astigmatism. corneal astigmatism can be reduced with a variety of surgical techniques including selective positioning of the phacoemulsification incision, corneal relaxing incision, implantation of toric iols, photorefractive keratectomy and there are first results of implantation of short arc-length intrastromal corneal ring segments for correcting astigmatism and myopia . the use of toric iols to reduce visually significant keratometric astigmatism offers a rational, more predictable and stable method of refractive correction. implanting a toric intraocular lens offers the possibility of correcting not only spherical equivalent of refraction, but also astigmatism. the success of a toric iol can be judged not only by its ability to reduce refractive astigmatism immediately postoperatively, but also by its ability to maintain a stable position in the capsular bag in the longer term. even a small rotational deviation of the toric iol from its intended axis can result in large reduction of the astigmatic correction. the purpose of this study is to evaluate and compare the visual outcomes, spectacle independency, visual disturbances (glares, halos), neuronal adaptation and patient satisfaction after implantation of either the liberty 677mty (a multifocal diffractive apodized toric intraocular lens- diffractive-refractive iol based on eps technology manufactured by medicontur ltd. zsámbék, hungary) or the multifocal toric panoptix® iol, manufactured by alcon.

Eligibility criteria:
inclusion criteria: the enrolled subjects will be the patients with cataract and pre-existing regular corneal astigmatism between 1.0 to 6.0 dpt. exclusion criteria: * astigmatism less than 1 dpt * irregular astigmatism * diabetic retinopathy * iris neovascularisation * serious intraoperative complications * congenital eye abnormality * glaucoma * pseudoexfoliation syndrom * amblyopia * uveitis * long-term anti-inflammatory treatment * amd (advanced amd) * retinal detachment * prior ocular surgery in personal medical history * corneal diseases * severe retinal diseases (dystrophy, degeneration) * severe myopia (if required iol power is lower than 10 d) * inadequate visualization of the fundus on preoperative examination * patients deemed by the clinical investigator because of any systemic disease. * eye trauma in medical history intraoperative exclusions: * tear in capsulorhexis * zonular dehiscence * posterior capsular rupture * vitreous loss and other unexpected surgical complication
a study of magnesium and bladder spasms following ambulatory urologic procedures

Conditions: Bladder Spasms

Summary: this research is being done to find out whether intravenous magnesium is effective in the treatment of bladder spasms after urologic surgery.


Eligibility criteria:
inclusion criteria: - be undergoing a bladder invasive procedure with or without planned urinary catheter on mayo clinic gonda 7 outpatient procedure center. exclusion criteria: * are unable to grant informed consent or comply with study procedure. * allergy or known sensitivity to magnesium or renacidin. * expected or high risk of bladder extravasation. * ongoing atrial fibrillation prior to surgery. * are undergoing emergency surgery. * are pregnant. * known hypermagnesemia. * patients with neuromuscular weakness (e.g., myasthenia gravis) due to magnesium's muscle weakening effect. * patients with myocardial compromise or cardiac conduction defects because of magnesium's anti-inotropic effects. * patients with renal insufficiency, glomerular filtration rate less than 30, since magnesium is eliminated by the kidneys resulting in exaggerated rise in serum magnesium. * patients with concomitant use of a calcium channel blocker since magnesium sulfate could act synergistically to suppress muscular contractility.
acute effects of motor imagery and physical exercise on tongue strength and pain threshold in healthy adults

Conditions: Motor Imagery Training; Physical Exercise; Orofacial Exercise

Summary: motor imagery is the feeling and thinking that the movement is done by imagination without physically occurring. in addition to its use in various fields, its use in the field of physiotherapy is also increasing. especially in situations where real movement is difficult or contraindicated, motor visualization is very advantageous when there is no physical contact. swallowing function is one of the vital functions that ensure human independence. like many components in swallowing, tongue muscle is also important. it has been shown that the strength of the tongue decreases with age, disease or other reasons. in the development of the strength of the tongue, while physiological principles are taken as basis, a different procedure from normal procedures is performed. however, language is a part of the body where one can study on his own. such situations lead to research on whether language reinforcement can occur with motor imagery. considering that in addition to long-term effects, acute effects may also affect the functions of individuals, the starting point of the study is formed. studies have investigated the acute change in tongue strength and pain perception after motor imagery. the primary aim of this study is compare the acute effects of different motor imagery methods and physical exercise on tongue strength and pain in heatlhy adults.


Eligibility criteria:
inclusion criteria: * participants age between 18-65 * symmetrical chewing function, fluent mouth and tongue movements exclusion criteria: * participants with systemic, cardiorespiratuar, central nerve system and romatologic diseases or musculoskeletal pain or craniocervical pathology * a history of orofacial pain or temporomandibular diseases. * over-reacting for touching or tooth-pain * pregnancy or possibility of pregnancy

Keywords: motor imagery tongue strength orofacial exercises